NCT01153789

Brief Summary

The eye movements of vergence allow binocular vision whatever the viewing distance or the body movements are and the perception of depth. Vergence dysfunction can lead to erroneous visual sensation of movements. In our daily life using screens (computer, game boys..) is increasing and this approach heavily the ocular vergence and can lead to symptoms if oculomotor and accommodative systems are dysfunctioning (Ped. Neurology 2000). Not knowing this pathology lead to inappropriate and expensive prescription CT scan or NMR. To evaluate the vergence performances just evaluation in static condition is currently available in ophthalmology departments. The CNRS laboratory (IRIS, FRE 3154) adapted a technic of eye movement recording to study ocular vergence in dynamic condition.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
183

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Sep 2010

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 29, 2010

Completed
1 day until next milestone

First Posted

Study publicly available on registry

June 30, 2010

Completed
2 months until next milestone

Study Start

First participant enrolled

September 1, 2010

Completed
3.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2014

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2014

Completed
Last Updated

December 4, 2014

Status Verified

August 1, 2013

Enrollment Period

3.4 years

First QC Date

June 29, 2010

Last Update Submit

December 3, 2014

Conditions

VertigoHeadacheAnomaly of Vergence SystemAccommodation DisordersOrthoptic Rehabilitation

Keywords

Vergence-accommodation evaluationVergence and postural controlDynamic visual acuity

Outcome Measures

Primary Outcomes (1)

  • oculomotor complete evaluation (static and dynamic and accommodation), posturography test and a visual dynamic acuity test

    t=0, t=3months, t=6months

Secondary Outcomes (1)

  • free of symptoms

    t=3months, t=6months

Study Arms (2)

Patients orthoptic rehabilitation

EXPERIMENTAL

Children with vertigo-headache and vergence disorders

Procedure: orthoptic rehabilitation

Control Orthoptic diagnostic

OTHER

Healthy controls

Other: Orthoptic diagnostic

Interventions

orthoptic rehabilitationPROCEDURE

Orthoptic rehabilitation: 12 sessions (2 sessions per week) At the end of a series of 12 sessions of orthoptic, the child will be examined and will again perform an static and dynamic oculomotor evaluation and control of postural balance.

Patients orthoptic rehabilitation
Orthoptic diagnosticOTHER

postural, oculomotor and orthoptics tests

Control Orthoptic diagnostic

Eligibility Criteria

Age6 Years - 17 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • Children with disorders of vergence:
  • to 17 years old
  • Patient receiving a social security scheme
  • Presenting vergence problems (diagnosed by standard methods : prism bar using the proximal point of convergence and phoria) and suffering from vertigo and/or headache
  • Presenting anormal refraction
  • Free from any type vestibular pathology, ENT or neurological
  • Free from strabismus
  • Child and holders of parental authority have signed a consent
  • Healthy Children :
  • to 17 years old
  • Free from any type of vestibular pathology, ENT or neurological
  • Free from any type of neuron-ophthalmic/orthoptic pathology
  • Child and holders of parental authority have signed a consent

You may not qualify if:

  • Patient with a disease which (from the assessment of the investigator) could disrupt the monitoring or be disrupted by the participation in the study,

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

ORL Service - Robert Debre Hospital

Paris, Paris, 75019, France

Location

MeSH Terms

Conditions

VertigoHeadache

Condition Hierarchy (Ancestors)

Vestibular DiseasesLabyrinth DiseasesEar DiseasesOtorhinolaryngologic DiseasesNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and SymptomsPain

Study Officials

  • Sylvette R WIENER, M.D., PhD

    Assistance Publique - Hôpitaux de Paris

    PRINCIPAL INVESTIGATOR

  • Thierry VAN DEN ABBEELE, M.D., PhD

    Assistance Publique - Hôpitaux de Paris

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 29, 2010

First Posted

June 30, 2010

Study Start

September 1, 2010

Primary Completion

February 1, 2014

Study Completion

August 1, 2014

Last Updated

December 4, 2014

Record last verified: 2013-08

Locations

FR(1)